A Randomized, Phase II, Double-Blind Study to compare the effect of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) versus WBRT Alone on Intracranial Disease progression in Patients with Brain Metastases from Non-Small Cell Lung Cancer

YM BioSciences Inc.0 个研究点目标入组 88 人开始时间: 2010年7月12日最近更新: 2020年1月13日

适应症

试验速览

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•1.Providing a written informed consent
•2.Age >=18 years;
•3.Histologic or cytologic confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) of any epithelial type (squamous, adenocarcinoma, large cell, or other);
•4.At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain not suitable for surgical resection
•5.Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
•6.Karnofsky performance status (KPS) >=70;
•7.Absolute neutrophil count >= 1500/mm^3;
•8.Platelet count >= 50,000/mm^3;
•9.Serum creatinine <=2.0 mg/dL;
•10.Serum transaminases <=2 x the upper limit of normal (ULN);
•11.Total serum bilirubin <=2 x ULN;
•12.Lactate dehydrogenase (LDH) level <=1.3 x ULN.
•13.Women of childbearing potential and men must agree to use adequate contraception (hormonal, or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately

•1.Pregnancy, lactation or parturition within the previous 30 days.
•2.Previous WBRT.
•3.Brain metastases resection with no other measurable lesion remaining.
•4.Extracranial metastases in two or more organs.
•5.Known leptomeningeal or subarachnoid tumor spread.
•6.Plan to use radiosurgery or radiation boost after completion of WBRT.
•7.Plan to use chemotherapy or any other antineoplastic modality during WBRT.
•8.Previous use of an anti-EGFR drug (e.g. Tarceva, Erbitux etc.).
•9.Patients receiving any other investigational agents.
•10.Presence of known seropositive Human immunodeficiency virus (HIV).
•11.Severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix).
•12.Hypersensitivity or allergy to any of the drugs to be administered in this study.
•13.Inability or unwillingness to complete the required assessments.
•14.Geographic inaccessibility for treatment or follow-up evaluations.

发起方